Drug Evaluation Committee 2012-11 Positioning of "Report" in a Clinical Trial Review Committee (Part 4)
Related classification: Clinical Trial Review Committee
First published: June 2012
Question
In the medical institutions that we are currently supporting, the head of the medical institution may, at the discretion of the head of the medical institution, make a " report" to the IRB for administrative changes such as the revision of the Appendix of the protocol as described in " 2010-12 Positioning of "Report" at the Clinical Trial Review Committee (Part 3) " that are not considered to affect the human rights or safety of the subjects in any way. In many cases, the IRB is not required to deliberate and report on such matters at the discretion of the head of the medical institution. In the above cases, the materials were kept only by the head of the medical institution (actually, the clinical trial office).
However, according to " 2010-12 Positioning of 'Reporting' in a Clinical Trial Review Committee (Part 3) " above, "It is acceptable for the secretariat of the clinical trial review committee to keep records to keep track of these changes." It is stated as follows. If the review is outsourced to a central IRB, the central IRB is supposed to keep records related to changes in many minor administrative matters that are not subject to deliberation or reporting. Is it necessary for each medical institution to submit to the Central IRB Office the materials related to changes in minor administrative matters that are not subject to review or reporting?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Please see previous Q&A 2009-12. The following statement is included.
Excerpt from 2009-12
The head of the site is required to keep the documents subject to IRB review up-to-date throughout the clinical trial period, and the latest documents submitted by the sponsor are also to be submitted to the IRB. At this time, if the content of the latest document falls under Article 31 of the GCP, or if the content falls under "other cases deemed necessary by the head of the site," as stipulated in Paragraph 2 of Article 31 of the GCP, the IRB must conduct a continuing review. On the other hand, there may be cases where the head of the site only submits the latest documents to the IRB at the discretion of the head of the site in response to the submission of the latest documents related to administrative changes from the sponsor, as you mentioned in your question.
When a document subject to review is added, updated, or revised in this way, the head of the site submits the relevant document to the IRB. This is no different in the case of the so-called Central IRB.